Indications for BREZTRI AEROSPHERE:
Maintenance treatment of COPD.
Limitations of Use:
Not indicated for relief of acute bronchospasm or for treatment of asthma.
2 inhalations twice daily (in the AM + PM). Max 2 inhalations twice daily. Rinse mouth after each use.
LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in acutely deteriorating COPD. Not for relief of acute symptoms. Prescribe a short-acting inhaled β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin prophylaxis or antiviral treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress or a severe COPD exacerbation. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), IOP, glaucoma, or cataracts. Discontinue immediately and treat if paradoxical bronchospasms or hypersensitivity reactions occur; use alternative therapy. Cardiovascular disorders (eg, coronary insufficiency, cardiac arrhythmias, hypertension). Assess for bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, advanced age, others). Urinary retention. Narrow-angle glaucoma. Prostatic hyperplasia. Bladder-neck obstruction. Hyperresponsiveness to sympathomimetics. Convulsive disorders. Thyrotoxicosis. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Severe hepatic impairment: monitor. Severe renal impairment or ESRD requiring dialysis. Pregnancy. Labor & delivery. Nursing mothers.
Corticosteroid + anticholinergic + long-acting beta-2 agonist (LABA).
Not for use with other drugs containing LABAs. Caution with concomitant strong CYP3A4 inhibitors (eg, long-term ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). Extreme caution with MAOIs, tricyclics, or drugs known to prolong QTc interval. Increased risk of reduction in bone mineral density with anticonvulsants, oral corticosteroids. Caution with concomitant other adrenergic drugs; may potentiate sympathetic effects. Concomitant xanthine derivatives, steroids, or diuretics may potentiate hypokalemia. Caution with non-K+-sparing diuretics. Antagonized by β-blockers; if needed, use cardioselective agents if no acceptable alternatives. Additive effects with concomitant other anticholinergic-containing drugs; avoid.
Upper RTI, pneumonia, back pain, oral candidiasis, influenza, muscle spasm, UTI, cough, sinusitis, diarrhea; paradoxical bronchospasm, hypersensitivity reactions, cardiovascular effects.
Inhalation aerosol—10.7g (120 inh)